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Scinai Immunotherapeutics Ltd 6-K, filed Jul 1, 2020

Scinai Immunotherapeutics Ltd. (SCNI)

6-K 2020-07-01 For: 2020-07-01
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Added on July 04, 2026

About this 6-K

Scinai Immunotherapeutics Ltd filed this 6-K on July 1, 2020.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of July 2020

Commission File Number: 001-37353

BIONDVAX PHARMACEUTICALS LTD.

(Translation of registrant’s name into English)

Jerusalem BioPark, 2nd Floor

Hadassah Ein Kerem Campus

Jeusalem, Israel

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒     Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

On June 30, 2020, BiondVax Pharmaceuticals Ltd. issued a press release announcing first quarter 2020 financial results.

Exhibit Index

Exhibit No. Description
99.1 Press Release dated June 30, 2020

This Report on Form 6-K is hereby incorporated by reference into the Company's Registration Statement on Form S-8 (Registration No. 333-239344).

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BiondVax Pharmaceuticals Ltd.
Date: July 1, 2020 By: /s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer
2

Exhibit 99.1

BiondVax AnnouncesFirst Quarter 2020 Financial Results

Jerusalem, Israel – June 30, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its first quarter financial results for the quarter ended March 31, 2020.

First Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and conveniencetranslation to $US is provided using the exchange rate of 3.57 (NIS/$US) as at March 31, 2020.

Total operating expenses for the first quarter were NIS 20.0 million (approximately $5.6 million) compared with NIS 7.1 million for the first quarter of 2019.

● R&D expenses for the first quarter amounted to NIS 19 million (approximately $5.3<br>million) compared with NIS 5.7 million for the first quarter of 2019.
● Net loss for the first quarter was NIS 3.7 million (approximately<br>$1.0 million) compared to net income of NIS 566 thousand for the first quarter of 2019.
--- ---

The increase in total operating expenses compared to the first quarter of 2019 was primarily due to expenses related to the ongoing Phase 3 trial and scale-up at our manufacturing facility.

As of March 31, 2020, BiondVax had cash and cash equivalents of NIS 42.5 million (approximately $11.9 million) compared to NIS 72.4 million as of December 31, 2019.

*Tables to follow*

About BiondVax

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.


Contact Details

Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Forward Looking Statements

Thispress release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as“expect,” “believe,” “intend,” “plan,” “continue,” “may,”“will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Theseforward-looking statements reflect the management’s current views with respect to certain current and future events and aresubject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected bythe management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to theCOVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequenttrials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacyand safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthyand expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual propertyand patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis,or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacyof available cash resources and the ability to raise additional capital when needed. More detailed information about the risksand uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available onthe SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

BALANCE SHEETS

In thousands, except share and per share data


Convenience
Translation
December 31 March 31, March 31,
2019 2019 2020 2020
Audited Unaudited Unaudited
N I S U.S. dollars
CURRENT LIABILITIES:
Trade payables 17,062 15,249 3,278 919
Operating lease liabilities 694 676 684 192
Other payables 1,203 1,275 807 226
18,959 17,200 4,769 1,337
LONG-TERM LIABILITIES:
Liability in respect of government grants 14,812 14,568 12,991 3,644
Operating lease liabilities 6,809 7,247 6,641 1,863
Loan from others 123,780 88,792 117,784 33,039
Warrants 16,354 2,059 6,861 1,925
Severance pay liability, net 89 84 90 25
161,844 112,750 144,367 40,496
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par value: Authorized: 600,000,000 shares at March 31, 2020 (unaudited) and at 391,000,000 shares at March 31, 2019 (unaudited) and December 31, 2019; Issued and outstanding: 410,213,977 shares at March 31, 2020 (unaudited), 261,419,599 shares at March 31, 2019 (unaudited) and 402,351,657 shares at December 31, 2019 *) - *) - *) - *) -
Share premium 73,867 179,987 262,729 73,697
Accumulated deficit (92,690 ) (210,578 ) (324,033 ) (90,893 )
(18,823 ) (30,591 ) (61,304 ) (17,196 )
33,493 99,359 87,832 24,637

*)     Represents less than NIS\USD 1.


STATEMENTS OF COMPREHENSIVEINCOME (LOSS)

In thousands, except shareand per share data

**** **** **** **** **** **** **** **** **** **** **** **** **** **** **** Convenience ****
**** **** **** **** **** **** **** **** **** **** **** **** **** **** translation ****
**** **** **** Year ended December 31, **** **** **** Three months ended<br><br> <br>March 31, **** **** **** Three months ended March 31, ****
**** **** **** 2019 **** **** **** 2019 **** **** **** 2020 **** **** **** 2020 ****
**** **** **** Audited **** **** **** Unaudited **** **** **** Unaudited ****
**** **** **** N I S **** **** **** U.S. dollars ****
Operating expenses:
Research and development, net of participations 68,645 5,732 19,068 5,348
Marketing, general and administrative 9,706 1,433 981 275
Total operating expenses 78,351 7,165 20,049 5,623
Operating loss (78,351 ) (7,165 ) (20,049 ) (5,623 )
Financial income 4 9,754 16,502 4,629
Financial expense (30,847 ) (2,023 ) (148 ) (42 )
Net income (loss) and total comprehensive income (loss) (109,194 ) 566 (3,695 ) (1,036 )
Basic and Diluted net income (loss) per share (0.33 ) 0.002 (0.01 ) (0.002 )
Weighted average number of shares outstanding used to compute basic and diluted income (loss) per share 326,651,721 261,419,599 408,596,752 408,596,752